An FDA-proposed study on adolescents’ risk perceptions will help determine what kinds of drugs require special care in direct-to-consumer advertising directed at this patient population, the agency believes.

In a Federal Register notice scheduled for publication July 21, the agency lays out its plans to test how adolescents process and respond to information in DTC ads promoting hypothetical Rx treatments for attention deficit hyperactivity disorder and acne.

The agency proposes to focus on three different factors that may influence adolescent understanding and perceptions of DTC ads: timing of the onset of benefits, timing of the onset of risks, and severity of risk.

“Although the variables we are examining are all attributes of the drug products themselves and do not reflect particular behaviors of sponsors, this information will be crucial in determining what types of prescription drugs may require additional care when advertising them to adolescents,” the notice states.

The adolescent survey is one of several DTC studies recently proposed by the agency. In May, the agency announced plans to study the impact of price comparisons in ads ([A#14140506002]).

FDA also has proposed a study that would use eye-tracking technology to determine how superimposed risk information and the MedWatch statement are perceived in DTC ads and the impact of distraction ([A#14140527002]).

Unique Audience Raises Special Concerns

Although sponsors for several prescription drug classes market their products directly to adolescents, such DTC ads have raised a variety of potential concerns, according to FDA.

“Adolescents are a unique audience for DTC drug marketing because their cognitive abilities are different than those of adults, and they are usually dependent on adults for health insurance coverage, health care provider access, and prescription drug payment,” the agency said. “Despite this uniqueness, research regarding how adolescents use risk and benefit information for health-related decisions is limited.”

FDA said that when age is taken into consideration in health care communication research, it is typically treated as simply another segment of the audience. Researchers fail to consider how information processing in response to DTC exposure might differ between adolescents and older viewers, according to the agency.

Nevertheless, existing theoretical and empirical data suggest that adolescence should be treated as a unique life stage during which vulnerabilities that can affect informed decision-making must be taken into consideration.

“The need for understanding how adolescents weigh risks and benefits is particularly critical given the potential adverse events associated with use of the drug classes that are marketed directly to adolescents,” FDA said.

The agency noted that suicide and suicidal ideation have been associated with some of these product classes, including the tretinoin class of acne treatments Also see "Suicidality Screening For All New Drugs Still On The Table After Draft Guidance" - Pink Sheet, 8 September, 2010..

Roche discontinued sales of its acne product Accutane (isotretinoin) in 2009, citing generic competition and the cost of personal injury lawsuits Also see "Roche Removes a Blemish: Drugmaker Drops Its One-Time Acne Blockbuster Accutane" - Pink Sheet, 26 June, 2009.. Currently marketed isotretinoin generics carry a label warning about the risk of psychiatric disorders, including suicidal ideation and attempts.

“Interpretation of more subtle messages in the advertisements, along with the lens through which adolescents view the message, must be understood,” FDA said.

Antidepressants also carry a boxed label warning about an increased risk of suicidal thoughts and behavior in children, adolescents and young adults in short-term studies Also see "FDA Extends Antidepressant “Black Box” Warning On Suicidality To Young Adults" - Pink Sheet, 7 May, 2007..

Given this type of risk with some products, “the risk and benefit information needs to be clearly presented in ways that adolescents can understand,” FDA said.

“Interpretation of more subtle messages in the advertisements, along with the lens through which adolescents view the message, must be understood. For example, given the potential stigma of acne and adolescents' heightened concerns about peer perceptions, marketing that emphasizes these two features in subtle ways might minimize the attention given to any risk information provided. This suggests the need to systematically explore the role of various factors that would be expected to influence adolescent decision-making, such as peer and family perceptions of stigma.”

Four Age Groups Surveyed

The agency proposes to conduct a randomized, controlled study using a 2 x 2 x 2 factorial design in two different medical conditions – acne and ADHD – to assess adolescents’ perceptions of different types of DTC ads.

Participants will be grouped according to younger adolescents (ages 13-15), older adolescents (ages 16-19), young adults (ages 25-30) and parents of participants in the two younger age groups.

Participants will view a web-based promotional campaign for either a fictitious ADHD or acne medication, and the ads will be similar to current web site advertisements produced for pharmaceutical companies. Adolescents’ perceptions of the ads will be compared to those of young adults.

“Because adolescents typically depend on their parents for prescription drug purchases, we also will include a sample of parents matched to their adolescent children to explore similarities and differences in perceptions for these matched pairs,” FDA said.

Within the two medical conditions, the agency will explore the impact of timing of benefit onset (immediate vs. delayed), timing of drug risk onset (immediate vs. delayed), and risk severity (low vs. high).

“Adolescents may be particularly likely to give more credence to benefits that occur immediately and may be likely to discount risks that do not occur immediately,” FDA said.

“Adolescents may be particularly likely to give more credence to benefits that occur immediately and may be likely to discount risks that do not occur immediately,” FDA said.

“Risk perceptions and risk taking have been active topics of exploration with regard to adolescents and thus the severity of the risks may play a role in determining whether and how adolescents attend to the benefit-risk profile of the prescription drugs they see advertised,” the agency said. “This factor will also help us generalize further to different types of products, although we recognize that it will not cover the gamut of prescription drug products.”

For the ADHD cohort, the agency will attempt to enroll participants who have been diagnosed with the condition. If a sufficient number of participants cannot be obtained, the study will be extended to include adolescents with family members who have been diagnosed with ADHD.

“Since acne is relevant for large numbers of people, it seems reasonable to draw the study sample from the general population,” the agency said.

Approximately 1,300 participants will be enrolled in each of the four age-based cohorts.

“Based on power analyses, the main study will include 5,120 completed participants, which will allow us enough power to test several possible covariates (factors other than our manipulated variables) that may have effects, such as demographic information.”

The agency’s original October 2013 request for feedback on the DTC adolescent study proposal resulted in two comments submitted to the docket. In response to one of the comments, FDA agreed to add an item to the survey instrument that measures participants’ previous experience with side effects from medications.

DTC Advertising For ADHD, Acne, Antidepressant Meds Could Shift After FDA Study

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